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Arrow IPN924881

by Teleflex Incorporated

Ref AI-01500-E

Arrow IPN924881 (AI-01500-E) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 11 Aug 2026 (Basic UDI-DI 08019020000000000000109KF), cleared under FDA 510(k) K883905 on 19 Jan 1989 and listed in FDA GUDID since 26 May 2022 (UDI-DI 10801902209105), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K883905

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000109KF Basic UDI-DI 10801902209105UDI-DIDate11 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902209105 UDI-DI Date26 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESD GUDID from GUDID Substantially Equivalent — Deferred · Traditional NumberK883905 Date19 Jan 1989DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000109KF registered 11 Aug 2026 Active
  • FDA 510(k) K883905 decided 19 Jan 1989 Active
  • FDA GUDID UDI-DI 10801902209105 listed 26 May 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K883905
  2. Listed FDA GUDID 10801902209105
  3. Registered EUDAMED 08019020000000000000109KF

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Pneumothorax Set EUDAMED
Arrow GUDID
Generic name
Pneumothorax catheter insertion set
Device name
Pneumothorax Catheter Product
Model / Ref / Catalog
AI-01500-E, IPN924881
Primary DI / UDI-DI
10801902209105
Basic UDI-DI
08019020000000000000109KF
510(k) Number
FDA product code
JOL
EMDN code
A060204 Thoracentesis and paracentesis drainages and kits
GMDN term
Pneumothorax catheter insertion set
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
880.6740
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AI-01500-E
GUDID
IPN924881
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pneumothorax catheter insertion set

Cleared under the same submission (K883905)

Similar devices in this category

Other devices filed under THORACENTESIS AND PARACENTESIS DRAINAGES AND KITS.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Contains latex
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Contains animal tissues or cells
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (15, all answered No)